Impax Labs gets US FDA tentative approval for generic Flomax capsules
Impax Laboratories, Inc confirmed that the US Food and Drug Administration (FDA) has granted tentative approval of the company's Abbreviated New Drug Application (ANDA) for generic version of Flomax (tamsulosin hydrochloride) 0.4mg capsules. Boehringer Ingelheim Pharmaceuticals, Inc markets Flomax for the functional symptoms of benign prostatic hyperplasia.
According to Wolters Kluwer Health, US sales of Flomax 0.4mg capsules were approximately $1.9 billion for the 12 months ended August 31, 2009.
Impax Labs is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products.